Study on the Risk of Allergy-like Reactions After Intra-arterial or Intra-venous Injection of the Marketed X-ray Contrast Medium Iopromid

NCT03622801 — Completed, 133331 participants, Bayer

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Risk of Anaphylactoid Reactions of Iopromide After Intra-arterial Administration

Registry	NCT03622801, acronym UVIA
Status	Completed
Study type	Observational
Enrollment	133331 (Actual)
Sponsor	Bayer (Industry)
Conditions	Contrast Medium
Interventions	Iopromide (Ultravist, BAY86-4877) (Drug)
Dates	start 2018-10-12, primary completion 2019-02-14, completion 2019-02-14, first posted 2018-08-09, last updated 2020-02-17
Locations	1 site in Germany

-Summary

Iopromide (trade name is Ultravist) is on the market for more than 30 years and has been used more than 250 million times as X-ray contrast medium for patients. It is known that Iopromide may cause allergy-like reactions after being injected. With this study researchers want to find out, if the risk of severe allergy-like reactions is lower, when Iopromide will be injected into an artery, compared to the risk after an injection of Iopromid into a vein. To find this out data from four trials on Iopromide that are already completed will be combined and newly analyzed. The database used for this analysis will contain data from more than 150,000 patients.

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+Arms and interventions

Arm	Type	Interventions	Description
Intra-arterial administration		Drug: Iopromide (Ultravist, BAY86-4877)	Patients with intra-arterial administration of Iopromide
Intravenous administration		Drug: Iopromide (Ultravist, BAY86-4877)	Patients with intravenous administration of Iopromide

Iopromide (Ultravist, BAY86-4877) (Drug): Patients who have received Iopromide (iodine concentrations of 300 mg/mL or 370 mg/mL) either intra-venously or intra-arterially.

+Outcome measures

Primary outcomes

Number of patients with anaphylactoid reactions of Iopromide after administration [Retrospective analysis from 31 Aug 2010 to 30 Sep 2011]

Secondary outcomes

Number of patients with anaphylactoid reactions after intra-arterial administration of Iopromide [Retrospective analysis from 31 Aug 2010 to 30 Sep 2011]
Number of patients with anaphylactoid reactions after intra-venous administration of Iopromide [Retrospective analysis from 31 Aug 2010 to 30 Sep 2011]

+Eligibility

Sex: All, ages: 18 Years to any

The study population consists of patients who received a contrast enhanced x-ray examination with Iopromide for various clinical reasons. Iopromide was administered either intra-venously or intra-arterially.

+Locations (1)

Facility	City	Country	Status
Many Locations	Multiple Locations	Germany

My Notes

Public

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